Prescription drug · ANDA
Alfuzosin Hydrochloride NDC 60505-2850
Alfuzosin hydrochloride 10 mg/1 · Tablet, Extended release · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-2850-9 | 60505285009 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (60505-2850-9)Marketed from Sep 8, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Alfuzosin Hydrochloride
- Generic name (nonproprietary)
- alfuzosin hydrochloride
- Active ingredients
- Alfuzosin hydrochloride — 10 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079013
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)
- Identifiers
- Product ID 60505-2850_42042f92-9e44-3c65-d85d-af81918b0d4eSPL ID 42042f92-9e44-3c65-d85d-af81918b0d4eSPL set ID 26fcc267-c8d7-e059-1bcf-830dded43690RxCUI 861132UNII 75046A1XTN
- Pharmacologic class
- alpha-Adrenergic Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460505285009followed by a unit qualifier and the quantityPackage 60505-2850-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hy…
Excerpt only. Read the full label for complete information.
About NDC 60505-2850
- What is NDC 60505-2850?
- 60505-2850 is the product NDC for Alfuzosin Hydrochloride, Alfuzosin hydrochloride 10 mg/1 tablet, extended release, listed with the FDA by Apotex Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alfuzosin Hydrochloride.
- What is the active ingredient?
- Alfuzosin hydrochloride.
- Who is the labeler?
- Apotex Corp., NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alfuzosin Hydrochloride?
- 14 other product NDCs are listed under this name. See all Alfuzosin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alfuzosin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 84386-153 | 84386-0153-0184386-0153-0584386-0153-30+2 more |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-967 | 51655-0967-52 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-087 | 51655-0087-52 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-432 | 51655-0432-52 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Unichem Pharmaceuticals (USA), Inc. | 29300-155 | 29300-0155-0129300-0155-1329300-0155-19 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-9155 | 63629-9155-0163629-9155-0263629-9155-03+1 more |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-945 | 43353-0945-1643353-0945-3043353-0945-60 |
| Alfuzosin hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Extended releaseOral | Exelan Pharmaceuticals Inc. | 76282-302 | 76282-0302-0176282-0302-0576282-0302-10+2 more |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Rising Pharma Holdings, Inc. | 57237-114 | 57237-0114-0157237-0114-0557237-0114-90 |
| Alfuzosin Hydrochloride | Alfuzosin hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 65862-249 | 65862-0249-0165862-0249-0565862-0249-30+2 more |